Compliance Specialist 2

求人内容

Primary Function of Position:The Safety Control Specialist is responsible to insure timely post-marketing filings (GVP) and complainthandling filings. Maintain post marketing and complaint handling documentation with necessary filingsand communications to appropriate parties. Communicate with government / regulatory agencies on alocal basis. Support the quality management activity in cooperation with QA team. Prepare andmaintain SOP for post-marketing filing, complaint handling and quality management.

資格

Roles and Responsibilities: Preparation and implementation of GVP in compliance with Japanese PAL. Collection and first reviewer of local and overseas post-marketing safety information. Complaint handling management for filings and prepare the customer letter. Communication with head office on complaint cases for preparation of customer letter. Support quality management activity and work with QA team to maintain the appropriate quality management system. Prepare and maintain the appropriate SOP for post-marketing filing, complaint handling and quality management in a timely manner. Continuous improvement and management of the safety/quality assurance process in accordance with Intuitive Surgical Product Development Process. Work directly with regulatory agencies on safety/quality issues and submissions. Documentation of Package Insert and PMDA web maintenance of Package Insert

Skill/Job Requirements: Educated and trained for post-marketing and/or quality management duties. Excellent ability to work in cross-functional environments. Strong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory documents. 3-5 years’ Experience working directly with the MHLW and other governmental agencies on Post marketing matters and/or Quality assurance matters. Friendly, positive attitude which fosters cooperation. Careful documentation of every step in a field action. Careful follow up of information sent to users and regulatory agencies. Understanding of Japan and international regulations regarding medical device safety / quality management.

その他の情報

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